NCT04976803

Tissue Collection for Correlation Between ATM Alterations by Next-Generation Sequencing and ATM Loss-of-Protein

A Tissue Collection Study to Explore the Correlation Between ATM Genetic Alterations by Next-Generation Sequencing and ATM Loss-of-Protein Via IHC (ATR-ID Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 229 (actual)
• Sponsor: Artios Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study examines the correlation between ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.

Detailed description

The purpose of this study is to address whether ATM genomic aberrations could be used to enrich for patients with ATM LoP. Screening of unselected patient populations for ATM protein loss is likely to a lead to high failure rate by IHC testing, as the prevalence of this is expected to be low. This study could allow for identification of the types of ATM aberrations that lead to ATM LoP, and thus significantly decrease IHC failure rate by pre-selecting patients harboring such aberrations. In this study the investigator will be collecting archival tumor tissue or fresh tissue which will be assessed for ATM LoP and compared to NGS data. Additionally, patients whose tumors exhibit ATM LoP within this study could potentially enroll onto the treatment study REFMAL 721/ART0380C001.

Conditions

• Solid Tumor, Unspecified, Adult

Interventions

Type	Name	Description
OTHER	Determination of ATM alteration status.	ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.

Timeline

• Start date: 2021-05-28
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-07-26
• Last updated: 2022-08-01

Locations

3 sites across 2 countries: United States, United Kingdom